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Study Director
4 months ago
SALARY: c. £50k+
STATUS: Full-time (but other working patterns will be considered)
POSITION TYPE: Permanent, Temp/Contract Work
LOCATION: York, On-site
The focus of this role is oversight and management of development, validation and sample analysis studies within the Bioanalytical Services –Small Molecules group. You will be responsible for delivering high quality results to our Sponsors and Clients in compliance with GLP and GCP.
WHAT WE OFFER:
- Auto Enrolment Pension
- Comprehensive Benefits Package
- Working within a Global organisation
- Career Advancement Opportunities including Apprenticeships
KEY RESPONSIBILITIES:
Quality:
- Follow the company’s Standard Operating Procedure(s) ensuring that all work conducted by them conforms to applicable regulatory standards, and biological and chemical safety regulations (COSHH).
- Maintain a current, and up-to-date, knowledge of company standard operating procedure(s).
- Contemporaneously maintain their individual training file, and ensure their work is carried in compliance to both standard operating procedure(s) and level of training recorded.
- Understand and use computer systems/policies and their associated software in order to carry out requisite duties of the post.
- Support departmental management in the effective running of the department, including owning/driving quality issue resolution and process improvement activities.
Study Management:
- Undertake study management of assigned studies. This includes, but is not limited to: managing Sponsor/Client/internal teams liaison activities.
- Generation of Study Protocols, Data Transfer Agreements and Analytical Reports.
- Batch construction for validations and sample analysis, in accordance with company SOPs and regulatory requirements.
- Scheduling work for assigned lab scientists. Ensure staff working on assigned studies are working in compliance with company SOPs, policies, study protocols, analytical methods and regulatory standards.
- Data checking/Quality Control (QC) review.
- Construction and submission of result tables/reports.
- Manage quality investigations and/or issue resolution; Corrective Action/Preventative Action (CAPA) system management.
- Ensure all data is archived in accordance with company SOPs and regulatory requirements.
- Responsible for financial monitoring for all assigned studies, ensuring all work is adequately accounted for during the revenue recognition process.
- Promote new business development activities by engaging in client interactions and supporting business development/management queries.
- Preparation of standard templates for others and author/review protocols, reports or standard operating procedure(s) as required by management.
- Maintain an up to date knowledge of public domain scientific advancements and technological improvements in the field of bioanalytical studies.
- Supports the maintenance of a profitable operation, identifies areas to improve revenue generation and control costs.
- Supports departmental management to effectively monitor budgets and operational costs; uses financial information to assist in decision making regarding staffing levels, workload and process management.
Technical:
- Train others, in the scientific theoretical methodology involved in the bioanalysis of macromolecules including sample management, batch preparation and data analysis.
- Understand and be capable of carrying out PK/TK, ADA and method validation/Sample analysis studies.
- Maintain an efficient data record with an appropriate audit trail.
- Understand the mathematical and statistical calculations used in generating results. To understand how to use analytical instrumentation and associated software to process and report analytical results and to understand the importance of audit trails, security and validation.
- Possess a deep understanding of company analytical equipment; use and maintenance, provide advice and guidance as necessary to support troubleshooting activities.
- Supervise/ direct method development for novel analytical methods, inclusive of sample preparation, data acquisition and processing, and generation of development reports.
ATTRIBUTES:
- A minimum of 3 years of study management experience in clinical and/or preclinical studies
- Strong background knowledge of large molecule analysis in support of PK and PD studies.
- Experience working in a regulatory environment, managing studies that are compliant with GLP/GCP
- Experience in a client facing role with the ability to provide high level advice and guidance to clients
- Non-Smoker: due to the nature of some of the testing carried out in the laboratory
The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the UK. CY Partners Recruitment Ltd, trading as CY Partners is an Employment Business/Agency.
